目的 对心肌肌钙蛋白I(cTnI)检测试剂AccTnI+3在DXI800和Access2化学发光分析仪上的分析性能进行验证,并建立我国表面健康人群的cTnI第99百分位值.方法 选择2014年10月至2015年6月来自武汉亚洲心脏病医院和北京阜外心血管病医院的1369名表面健康者和20例急性心肌梗死患者,其中表面健康者男性680例,女性689例.18~30岁340例,31~64岁674例,≥65岁355例.参考美国临床实验室标准化研究所(CLSI)的 EP15-A2和 EP17-A2文件,验证AccuTnI+3的检出限和不精密度;使用Bland Altman图和Passing-Bablok回归分析两种化学发光分析仪DXI800和Access2的一致性;使用线性回归分析不同样本类型(肝素锂血浆、EDTA血浆和血清)的检测值的相关性.检测1369名表面健康人的肝素锂血浆cTnI浓度,计算第99百分位值;并按照不同年龄和性别分组,比较各年龄组之间和性别组之间的cTnI水平,计算各个组的第99百分位值.使用SPSS23.0统计表面健康人群中的 cTnI 检出率.结果 AccuTnI +3的空白检测限(LoB)为0.006 ng/ml(DXI800)和0.007 ng/ml(Access2);最低检出限(LoD)为0.010 ng/ml(DXI800)和0.012 ng/ml(Access2).总不精密度(CV%)10%对应的cTnI浓度(LoQ)为0.016 ng/ml(DXI800)和0.026 ng/ml(Access2).DXI800和Access2的cTnI检测结果一致性较好.肝素锂血浆、EDTA血浆和血清样本的cTnI检测值两两线性相关:EDTA血浆检测值=0.76肝素锂血浆检测值,R2=0.999(n=40, P<0.001);血清检测值=1.05肝素锂血浆检测值,R2=0.996(n=40, P<0.001);血清检测值=1.38 EDTA血浆检测值,R2=0.993(n=40,P<0.001).1369名表面健康者的AccuTnI+3第99百分位值为0.030 ng/ml(DXI800)和0.035 ng/ml(Access2);高年龄组的cTnI水平高于低年龄组;18~30岁、31~64岁、≥65岁的第99百分位值分别为:DXI800为0.011 ng/ml、0.029 ng/ml、0.035 ng/ml;Access2为0.023 ng/ml、0.034 ng/ml、0.045 ng/ml.男性的cTnI水平高于女性.男性和女性的第99百分位值分别为:DXI800为0.034 ng/ml和0.032 ng/ml;Access2为0.043 ng/ml和0.031 ng/ml.表面健康人群中的cTnI的检出率为62%(DXI800)和87%(Access2).结论 AccuTnI+3的分析性能满足临床使用的要求,也满足高敏肌钙蛋白试剂的标准.%Objective To validate the analytical performance of a cardiac troponin I(cTnI)assay AccuTnI+3 on chemiluminescnet analyzer DXI800 and Access2;and to establish the 99th percentile of cTnI in an apparently healthy Chinese population.Methods The subjects are composed of 1 369 apparently healthy people and 20 acute myocardial infarction(AMI)patients from Wuhan Asian Heart Hospital and Fuwai Hospital from October 2014 to June 2015.The healthy people include 680 males and 689 females;with 340 subjects aged 18-30,674 subjects aged 31-64, and 355 subjects aged ≥65.The detection limits and imprecision of AccuTnI +3 assays were validated according to CLSI EP 15-A2 and EP17-A2 documents;the same samples were analyzed on DXI800 and Access2 to assess the consistency between the two analyzers using Bland Altman plot and Passing-Bablok regression.The correlation between different sample types (lithium heparin plasma, EDTA plasma & serum)were assessed using linear regression analysis.The lithium heparin plasmasamples from 1 369 apparently healthy people were analyzed to calculate the 99th percentile of cTnI.The cTnI concentrations were compared among age and sex groups.The 99th percentile of cTnI were also calculated for each group.The detection rate of cTnI in apparently healthy people was calculated using SPSS23.0.Results The limit of blank(LoB), limit of detection(LoD), and limit of quantification(LoQ)where CV%=10% were 0.007 ng/ml,0.010 ng/ml and 0.016 ng/ml on DXI800;0.008 ng/ml,0.012 ng/ml and 0.026 ng/ml on Access2,respectively.The cTnI measurements on DXI800 and Access2 were consistent and comparable.The cTnI concentrations of lithium heparin plasma, EDTA plasma and serum samples were linearly correlated pairwise: EDTA plasma measuremen t =0.76 heparin plasma measurement, R2=0.999(n=40, P<0.001); serum measuremen t =1.05 heparin plasma measurement,R2=0.996(n=40,P<0.001); serum measuremen t=1.38 EDTA plasma measurement, R2=0.993(n=40,P<0.001).The 99th percentiles were 0.030 ng/ml and 0.035 ng/ml on DXI800 and Access2,respectively,from 1 369 apparently healthy Chinese people.cTnI is significantly higher in elder group than in younger group.The 99th percentiles in 18-30 years old group,31-64 years old group,and≥65 years old group are:0.011 ng/ml,0.029 ng/ml,and 0.035 ng/ml respectively for DXI800;0.023 ng/ml,0.034 ng/ml, and 0.045 ng/ml respectively for Access2.cTnI is significantly higher in men than in women.The 99th percentiles in men and women are: 0.034 ng/ml and 0.032 ng/ml respectively for DXI800;0.043 ng/ml and 0.031 ng/ml respectively for Access2.cTnI was measurable in 62%and 87%of healthy subjects on DXI800 and Access2 systems,respectively.Conclusions The analytical performance of AccuTnI+3 assay fulfills the need of clinical use and the criteria of high-sensitive cardiac troponin assay.
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